KAMIREN 4 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Kamiren XL, 4 mg, Prolonged-Release Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Kamiren XL and what is it used for
4. Important information before taking Kamiren XL
   1. When not to take Kamiren XL:
   2. Warnings and precautions
   3. Children and adolescents
   4. Kamiren XL and other medicines
   5. Kamiren XL with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Kamiren XL contains lactose
5. How to take Kamiren XL
   1. What to do if you take more Kamiren XL than you should
   2. What to do if you miss a dose of Kamiren XL
6. Possible side effects
   1. Common side effects (may affect up to 1 in 10 people):
   2. Uncommon side effects (may affect up to 1 in 100 people):
   3. Rare side effects (may affect up to 1 in 1,000 people):
   4. Very rare side effects (may affect up to 1 in 10,000 people):
   5. Side effects with unknown frequency (frequency cannot be estimated from available data):
   6. Reporting side effects
7. How to store Kamiren XL
8. Contents of the pack and other information
   1. What Kamiren XL contains
   2. What Kamiren XL looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

Kamiren XL, 4 mg, Prolonged-Release Tablets

Doxazosin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Kamiren XL and what is it used for
• 2. Important information before taking Kamiren XL
• 3. How to take Kamiren XL
• 4. Possible side effects
• 5. How to store Kamiren XL
• 6. Contents of the pack and other information

1. What is Kamiren XL and what is it used for

Kamiren XL lowers blood pressure by reducing the resistance of blood vessels. Additionally, it reduces the symptoms associated with difficulty in urinating. Kamiren XL is indicated for the treatment of high blood pressure. It can be used as monotherapy (as the only medicine) or in combination with other antihypertensive medicines, such as thiazide diuretics, beta-adrenergic blockers, calcium antagonists, or angiotensin-converting enzyme inhibitors. Kamiren XL is also indicated for the treatment of symptoms caused by benign prostatic hyperplasia. It can be used in both patients with high blood pressure and those with normal blood pressure. In patients with high blood pressure, it can also lower blood pressure. In patients with normal blood pressure, the effect on blood pressure is usually insignificant.

2. Important information before taking Kamiren XL

When not to take Kamiren XL:

• if you are allergic to doxazosin, other quinazoline derivatives (prazosin, terazosin), or any of the other ingredients of this medicine (listed in section 6); these may be itching, redness of the skin, or difficulty breathing,
• in patients with gastrointestinal obstruction, esophageal, or reduced diameter of the gastrointestinal tract in history,
• in patients with enlarged prostate (benign prostatic hyperplasia) andlow blood pressure,
• in patients who have previously experienced orthostatic hypotension, i.e., low blood pressure causing dizziness or disorientation when standing up from a sitting or lying position,
• in patients with enlarged prostate, with one of the following symptoms: obstruction or blockage of the urinary tract of any type, prolonged urinary tract infection, or stones in the bladder,
• in patients with urinary incontinence due to overflow (not feeling the need to urinate) or anuria (the body does not produce urine) with kidney function disorders or without them.

Warnings and precautions

Before starting treatment with Kamiren XL, consult your doctor or pharmacist. In particular, inform your doctor about:

• liver function disorders; in patients with established liver failure, doxazosin is not recommended.
• heart disorders (pulmonary edema caused by aortic stenosis or mitral stenosis, heart failure with high minute volume, right ventricular heart failure caused by pulmonary embolism or pericardial effusion, left ventricular heart failure with low filling pressure), rapid and significant lowering of blood pressure may worsen angina symptoms.
• taking other medicines, e.g., sildenafil, tadalafil, vardenafil (medicines used for impotence), as symptomatic hypotension may occur.

Patient undergoing eye surgery for cataracts should inform the ophthalmologist before surgery that they are taking or have recently taken Kamiren XL. This will allow the doctor to take appropriate precautions or choose an appropriate surgical technique to avoid possible complications. Prolonged, painful erections can occur very rarely. In such cases, contact your doctor immediately. At the beginning of taking Kamiren XL, when standing up from a sitting or lying position, the patient may feel dizzy or lightheaded due to low blood pressure. If dizziness or lightheadedness occurs, sit or lie down and wait until the symptoms pass to avoid situations that may lead to falls or injuries. At the beginning of treatment, the doctor may regularly measure blood pressure to reduce this risk.

Children and adolescents

Kamiren XL is not recommended for use in children and adolescents under 18 years of age, as the safety and efficacy of doxazosin in this age group have not been established.

Kamiren XL and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Ask your doctor or pharmacist before taking Kamiren XL if you are taking any of the following medicines, as they may change the effect of Kamiren XL:

• In some patients taking alpha-adrenergic medicines to lower high blood pressure or treat prostate enlargement, dizziness or a feeling of "emptiness in the head" caused by low blood pressure may occur when standing up quickly from a lying or sitting position. These symptoms can occur in some patients taking medicines for erectile dysfunction (impotence) with alpha-adrenergic medicines. To reduce the likelihood of these symptoms, patients should take alpha-adrenergic medicines, including Kamiren XL, at least 6 hours before taking medicines for erectile dysfunction.

Kamiren XL may further lower blood pressure in patients already taking other antihypertensive medicines, such as terazosin and prazosin.

• Medicines used to treat bacterial or fungal infections, e.g., clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole.
• Medicines used to treat HIV infection, e.g., indinavir, nelfinavir, ritonavir, saquinavir.
• Nefazodone, a medicine used to treat depression.
• Vasodilators or nitrates (medicines used for heart diseases).

In vitro studies have not shown that doxazosin affects the binding of digoxin, warfarin, phenytoin, or indomethacin to plasma proteins. In clinical studies, no interactions have been found between doxazosin and thiazide diuretics, furosemide, beta-adrenergic blockers, non-steroidal anti-inflammatory medicines, antibiotics, oral hypoglycemic medicines (used for diabetes), medicines that increase uric acid excretion, and anticoagulant medicines. Kamiren XL enhances the blood pressure-lowering effect of other alpha-adrenergic blockers and other antihypertensive medicines. Clinical studies have shown that doxazosin has a beneficial effect on lipids, significantly reducing total triglyceride, total cholesterol, and LDL fraction levels in serum. Treatment with doxazosin has a beneficial effect on high blood pressure and lipid levels, resulting in a reduced risk of coronary artery disease.

Kamiren XL with food and drink

Kamiren XL can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Since the safety of doxazosin during pregnancy has not been established, Kamiren XL can be used during pregnancy only when the potential benefits to the mother outweigh the risks to the fetus. Doxazosin passes into human milk in small amounts. Breastfeeding women should not take this medicine unless the doctor decides otherwise.

Driving and using machines

Due to the possibility of dizziness, especially at the beginning of treatment with Kamiren XL, after increasing the dose, switching to another product, or when consuming alcohol, it is not recommended to drive vehicles or operate machines.

Kamiren XL contains lactose

If you have been diagnosed with an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Kamiren XL

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. The initial dose of Kamiren XL is 4 mg once daily. A daily dose of 4 mg is effective in most patients. If the expected blood pressure reduction after 4 weeks of treatment is not satisfactory and the patient tolerates the treatment well, the doctor may increase the dose to 8 mg once daily. The maximum recommended daily dose is 8 mg once daily. Use in elderly patients: There is no need to reduce the dose in elderly patients. Use in patients with renal impairment: There is no need to reduce the dose in patients with renal impairment. Patients with liver function disorders: In patients with liver function disorders, the medicine should be used with caution. In patients with established liver failure, doxazosin is not recommended. Swallow the tablets whole with a sufficient amount of liquid; do not chew, break, or crush them. If you feel that the effect of Kamiren XL is too strong or too weak, consult your doctor.

What to do if you take more Kamiren XL than you should

If you take more Kamiren XL than you should, significant lowering of blood pressure may occur. Your doctor will administer symptomatic treatment. Dialysis is not effective, as doxazosin is almost completely bound to proteins. If you take more medicine than you should, contact your doctor or pharmacist immediately.

What to do if you miss a dose of Kamiren XL

If you miss a dose, do not take a double dose to make up for the missed dose. Take the next dose according to the recommended schedule. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people):

• respiratory tract infections (nose, throat, lungs), urinary tract infections,
• dizziness, headache, drowsiness,
• feeling of spinning (vertigo),
• rapid heartbeat (tachycardia), feeling of heartbeat,
• low blood pressure or a drop in blood pressure when standing up, causing dizziness, a feeling of "emptiness in the head," or fainting (orthostatic hypotension),
• bronchitis, cough, shortness of breath, swelling of the nasal mucosa, sneezing, and (or) runny nose, caused by inflammation of the nasal mucosa,
• stomach/abdominal pain, nausea, dry mouth, nausea,
• itching,
• back pain, muscle pain,
• urinary tract infection, urinary incontinence,
• general weakness, chest pain, flu-like symptoms, swelling of the feet, ankles, or toes.

Uncommon side effects (may affect up to 1 in 100 people):

• allergic reactions,
• increased or decreased appetite, joint inflammation (gout),
• anxiety, depression, insomnia,
• stroke, fainting, tremor, sensory disturbances in hands and feet,
• ringing in the ears,
• heart attack, chest pain (angina pectoris),
• nosebleeds,
• constipation, flatulence, gastritis, diarrhea, vomiting,
• abnormal liver function test results,
• skin rash,
• joint pain,
• pain or discomfort when urinating, frequent urination, blood in the urine,
• impotence,
• facial swelling, general pain,
• weight gain.

Rare side effects (may affect up to 1 in 1,000 people):

• gastrointestinal obstruction.

Very rare side effects (may affect up to 1 in 10,000 people):

• low white blood cell or platelet count, which can cause bruising or increased bleeding tendency (leukopenia, thrombocytopenia),
• restlessness, nervousness,
• fainting or dizziness caused by low blood pressure when standing up from a sitting or lying position, feeling of tingling or numbness in hands and feet,
• vision disturbances,
• slow or irregular heartbeat,
• hot flashes,
• wheezing (caused by bronchospasm),
• hepatitis or bile duct disorders, yellowing of the skin or eyes (jaundice),
• hives, hair loss,
• red or purple spots on the skin, subcutaneous bleeding (purpura),
• muscle cramps, muscle weakness,
• urination disorders, nocturia, increased urine output,
• breast enlargement in men (gynecomastia),
• prolonged, painful erection (priapism) - seek medical attention immediately,
• fatigue, general malaise.

Side effects with unknown frequency (frequency cannot be estimated from available data):

• eye disorders that may occur during cataract surgery (lens opacity), see "Warnings and precautions",
• absence or low amount of semen during ejaculation, cloudy urine after ejaculation.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Kamiren XL

Keep this medicine out of the sight and reach of children. There are no special precautions for storage. Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month stated. The batch number is stated on the packaging after "Lot". Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Kamiren XL contains

• The active substance is doxazosin. Each prolonged-release tablet contains 4 mg of doxazosin, in the form of doxazosin mesylate.
• The other ingredients are hypromellose, calcium hydrogen phosphate, lactose monohydrate, magnesium stearate; coating: Opadry White Y-1-7000 [hypromellose, titanium dioxide (E 171), macrogol 400].

What Kamiren XL looks like and contents of the pack

White, round, slightly convex prolonged-release tablets. Pack sizes: 30, 60, or 90 prolonged-release tablets in blisters in a cardboard box.

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia. For more information about this medicine, contact the local representative of the marketing authorization holder: KRKA-POLSKA Sp. z o.o., ul. Równoległa 5, 02-235 Warsaw, phone: +48 22 573 75 00.

Date of last revision of the leaflet: